The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Condition	Intervention	Phase
energy deficiency due to short-term fasting	Drug: r-metHuLeptin	Phase I

Further Study Details: 

Primary Outcomes: leptin pharmacokinetic parameters
Secondary Outcomes: neuroendocrine hormone levels; adipokine hormone levels; cytokine levels
Expected Total Enrollment:  20

Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.

Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state

Ages Eligible for Study:  18 Years   -   30 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• healthy men with body mass indices (BMI) <25 kg/m2)
• overweight otherwise healthy men with BMI > 27 kg/m2
• healthy lean women with BMI<25 kg/m2
• overweight otherwise healthy women with BMI > 27 kg/m2

Exclusion Criteria:

• history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)
• on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)
• known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins
• women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States

Study chairs or principal investigators

Christos S Mantzoros, MD DSc FACP FACE,  Principal Investigator,  Beth Israel Deaconess Medical Center   
Jean L Chan, MD,  Study Director,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  2001-P-000260
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140205
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13